MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	D-EVPROP2329US
Medical Device Problem Codes	Material Invagination (1336); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during implant of this transcatheter bioprosthetic valve into a patient with a large calcium burden in the annulus, the valve was partially deployed and dislodged toward the aorta.The valve was recaptured and an infold was noted.The valve was removed.A new valve was loaded with a new delivery catheter system (dcs) and successfully implanted.Per the physician, calcium in the annulus contributed to the infold.No adverse patient effects were reported.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.This is a system report.The section d information is for the primary device, which was in use with the following: product id: evproplus-29us, serial#: (b)(6), ubd: 05-oct-2023, udi#: (b)(4), product analysis: upon receipt of the suspect complaint valve at medtronic¿s quality laboratory, the device was received in its original jar submerged in clear solution.Visual analysis showed the valve was discolored with evidence of blood contact.All leaflets were slightly stiff yet flexible.All leaflets exhibited signs of severe creases and imprints, conditions resulting from the crimping and recapturing process.As received, all leaflets were partially closed with large gap between all free margins.Blood remnants were noted on all commissures; appeared intact.The valve was then placed in a cold saline bath to perform loading simulation per appropriate instructions for use (ifu).Upon loading, both frame paddles appeared seated within the paddle attachment pockets.The capsule was advanced covering the frame paddles and outflow crown struts.The capsule was advanced until the capsule guide tube covered the commissure pad of the valve.The inflow cone was advanced to crimp the inflow portion of the valve.The capsule was fully advanced over the valve; no visual or tactile anomalies were noted.To simulate the reported event, the valve was deployed in a warm saline bath by rotating the deployment knob exposing the valve.The valve continued to be deployed up to the point of no recapture; no anomalies were observed.At this point, the valve was recaptured and appeared to retract without issues or anomalies.The valve was subsequently deployed and appeared to exhibit a complete dilation; no anomalies were observed.Conclusion: the device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Infolding events are typically related to patient anatomical factors (i.E., calcification level, lvot anomalies, compliance of the annulus, bicuspid valve, etc.) and/or procedural factors (i.E., pre-case planning, sizing, loading, user technique, etc.).Additionally, the valve frame is constructed with nitinol and the latticed strut design allows the valve to be compressed and loaded into the delivery system.During either the loading or deploying/recapturing process, the struts may cross over and catch on each other while being compressed, and potentially cause infolding.As reported per the physician, calcium in the annulus contributed to the infold.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.In this case it was reported that the patient had a large calcium burden in the annulus, which indicates that the probable cause of the reported dislodgement was patient anatomy.Dislodgement events do not typically indicate a failure to meet manufacturing specifications there is no information to suggest a device quality deficiency that may have caused or contributed to this event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT PRO PLUS DCS
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21967758
• Report Number: 2025587-2025-03423
• Device Sequence Number: 15579203
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010905769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/06/2025
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male